Hologic & Cepheid’s Diagnostic Tests Receive 510(k) Clearance for Extragenital Testing in Chlamydia and Gonorrhea

 Hologic & Cepheid’s Diagnostic Tests Receive 510(k) Clearance for Extragenital Testing in Chlamydia and Gonorrhea

Hologic & Cepheid’s Diagnostic Tests Receive 510(k) Clearance for Extragenital Testing in Chlamydia and Gonorrhea

Shots:

  • The approval follows the clinical study assessing Hologic’s Aptima Combo 2 Assay and Cepheid’s Xpert CT/NG in 2,500+ patients to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae through diagnostic testing of extragenital specimens
  • The study results demonstrated that Aptima Combo 2 Assay and the Xpert CT/NG for extragenital specimens are safe and effective for extragenital testing in chlamydia and gonorrhea via throat and rectum
  • The Aptima Combo 2 Assay & Xpert CT/NG is a nucleic acid probe test & in vitro real-time PCR test used for qualitative detection and differentiation of rRNA & genomic DNA to diagnose CT & GC using Tigris DTS System/Panther system & GeneXpert Instrument Systems respectively

Click here to read full press release/ article | Ref: US FDA | Image: ResearchGate, Clinical Laboratory

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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